Completed PHASE2 INTERVENTIONAL 2-arm NCT00476151

A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of EpiCept™ NP-1 Topical Cream in Patients With Pain From Diabetic Peripheral Neuropathy (DPN)

Sponsor: EpiCept Corporation

Conditions Diabetic Peripheral Neuropathy Neuralgia

Interventions EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream placebo cream

Updated 6 times since 2017 Last updated: Apr 19, 2011 Started: Jul 31, 2007 Primary completion: Apr 30, 2008 Completion: Apr 30, 2008

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Diabetic Peripheral Neuropathy and Neuralgia and is currently completed. EpiCept Corporation leads this study, which shows 6 recorded versions since 2007 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2
Feb 2017 — Jun 2018 [monthly]

Completed PHASE2

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Jul 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

EpiCept Corporation

Data source: EpiCept Corporation

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• New Delhi, India